Mexico gives Novavax approval for swine flu shot


swine-vaccineI was excited to read about a new swine flu vaccine that is developed by Novavax and is moving forward with clinical trails.  The more interesting fact is new vaccine by Novavax will be in human trials in Mexico, where wine flu started. I had done a comprehensive research on the current shortage of swine flu vaccine.  The two main limitations that stood out were the technology to produce flu vaccine was 50 year old, which has poor yields and high cycle time; secondly testing of the vaccine to confirm dose of vaccine itself adds to the time of production.  Well the good news is Novavax found a new way to produce flu vaccine.  Let us take a look at information related to H1N1 vaccine developed by Novavax.


How different is Novavax technology from conventional way of making Flu shots?

swine-flu-vaccine-technologyThe 50 year old flu vaccine technology involves growth of flu virus in chicken eggs.  Then the vaccine is purified and tested.  Hundreds and thousands of eggs from chickens are infected with flu virus and then purified to make killed virus vaccine.  It is estimated that roughly one egg is required for every dose of flu vaccine.  The cycle time to develop a new vaccine with this 50 year old technology is around four to five months.

Novavax, based in Rockville, Maryland has developed a virus like particle (VLP) technology, a technique that genetically engineers flu vaccine in insect cells.  A structure similar to a virus is build by Novavax scientists except for the genetic material required for viral replication, without the use of an adjuvant. Once injected into the body, VLPs attach to cells and trigger an immune response sufficient enough to protect a person, if they are exposed to the virus.


gsk-101609Has this type of technology used before?

Rahul Singhvi, Novavax’s chief executive and former head of vaccine manufacturing at Merck acknowledged that VLC was also used to make newly approved vaccine for human papilloma virus (HPV), Cervarix from GlaxoSmithKline (GSK).  GSK Carvarix also uses particles in similar type of insect cells. 


swine-fluWhen is the vaccine expected in market?

The Novavax’s vaccine has got heads up from Mexican authorities to conduct a trial against H1N1 virus in a human population of 3,000.  The study is designed to expose and get infections to 2,000 participants who will receive Novavax’s shots against 1,000 who don’t. If their immune systems respond and the vaccine appear safe, Mexican regulators would be likely to approve it, Singhvi says.  Novavax is shooting for selling the vaccine in Mexico in 2010.  Novavax has partnered with Avimex, a Mexican vaccine maker for the...

study and with General Electric (GE) healthcare unit, who is manufacturing the vaccine. 


cell-ecoliAre there any other technologies as alternatives for vaccine production?

Vaxlnnate, Cranbury, NJ based company is working on a technology that can produce swine flu vaccine in just six weeks.  The technology is based on producing vaccine in Escherichia coli (E-coli) bacteria has potential to produce vaccine quickly and cheaply.  Alan Shaw, CEO of VaxInnate (another Merck veteran), says that “You could vaccinate everybody on the planet without breaking a sweat”. The E-Coli bacteria make a protein that fuses part of the flu virus to another protein that is a trigger for the immune system. The trigger, flagellin, is the stuff that swimming germs use to make their tails, and it spurs the body to create antibodies immediately.

DNA-based-swine-vaccineVical, of San Diego, California, is developing a technology under an agreement with US Navy.  The swine flu vaccines technology involves delivering DNA into cells.  The recent animal study results show the DNA-based vaccine prompted responses above the accepted protection threshold in mice and rabbits with strains from recent outbreaks in California, Texas, and Mexico.

Novartis is working on swine flu vaccine in which seed virus was grown in kidney cell culture of Madin-Darby Cannine, basically a dog. The manufacturing process is similar to the one used for the development of Optaflu vaccines against interpandemic influenza. The vaccine was formulated and produced by Novartis (Marburg, Germany) as an inactivated surface-antigen H1N1 vaccine. Novartis is building a cell culture flu vaccine factory in Holly Springs, N.C., which might be ready for use in 2010 or 2011. The federal government is providing nearly $500 million in construction costs and guaranteed vaccine purchases.




I am thrilled about the new ways to produce flu shots.  It is surprising at the same time good that the government such as Mexican has approved the testing of the vaccine in such a short period of time.  Otherwise, it can take years to deal with bureaucratic regulatory bodies to get approval for a new drug.  


Healthy vaccination! 



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